Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

Blood Loss, Surgical Clinical Trial

Official title:

Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00657384
• Other study ID #: 3959
• Status: Terminated
• Phase: Phase 3
• Start date: August 20, 2008
• Est. completion date: November 2013

Study information

• Verified date: February 2021
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (> 3 hepatic segments).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: November 2013
• Est. primary completion date: August 20, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signature of the consent form

• Patients with hepatic lesion needing a major hepatectomy (= 3 hepatic segments)

Exclusion Criteria:

• Absence of signature of the consent form

• Patient with cirrhosis

• Minor hepatectomy (< 3 hepatic segments)

• Hepatectomy associated with vascular resection

• Contraindication of tranexamic acid : history of arterial or venous thrombosis , disseminated intravascular coagulation, severe renal insufficiency, history of epilepsies , intrathecal or intraventricular injection

• Pregnant or lactation

Related Conditions & MeSH terms

• Blood Loss, Surgical

Intervention

Drug:
• acid tranexamic
10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention.
• Nacl 0.9%
10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention

Locations

Country	Name	City	State
France	CHU Amiens, Hôpital Nord	Amiens
France	Chirurgie digestive et transplantation, Hôpital de Besançon	Besançon
France	CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André)	Bordeaux
France	Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The volume of compensated blood loss with the formula: [TBV x (initial hematocrit - final hematocrit ) + number of transfused RBC unit] with TBV=Total Blood Volume and RBC= red blood cell (1 RBC unit = 500 ml with hematocrit=30%).		at day 5